Bmc Med Res Methodol
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Bmc Med Res Methodol · Jan 2013
ReviewQualitative systematic reviews of treatment burden in stroke, heart failure and diabetes - methodological challenges and solutions.
Treatment burden can be defined as the self-care practices that patients with chronic illness must perform to respond to the requirements of their healthcare providers, as well as the impact that these practices have on patient functioning and well being. Increasing levels of treatment burden may lead to suboptimal adherence and negative outcomes. Systematic review of the qualitative literature is a useful method for exploring the patient experience of care, in this case the experience of treatment burden. There is no consensus on methods for qualitative systematic review. This paper describes the methodology used for qualitative systematic reviews of the treatment burdens identified in three different common chronic conditions, using stroke as our exemplar. ⋯ The creation of our search strategy may be of particular interest to other researchers carrying out synthesis of qualitative studies. Importantly, the successful use of NPT to inform a coding frame for data analysis involving qualitative data that describes processes relating to self management highlights the potential of a new method for analyses of qualitative data within systematic reviews.
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Bmc Med Res Methodol · Jan 2013
Selecting optimal screening items for delirium: an application of item response theory.
Delirium (acute confusion), is a common, morbid, and costly complication of acute illness in older adults. Yet, researchers and clinicians lack short, efficient, and sensitive case identification tools for delirium. Though the Confusion Assessment Method (CAM) is the most widely used algorithm for delirium, the existing assessments that operationalize the CAM algorithm may be too long or complicated for routine clinical use. Item response theory (IRT) models help facilitate the development of short screening tools for use in clinical applications or research studies. This study utilizes IRT to identify a reduced set of optimally performing screening indicators for the four CAM features of delirium. ⋯ We identified optimal indicators from a large item pool to screen for delirium. The selected indicators maintain fidelity to clinical constructs of delirium while maximizing psychometric information important for screening. This reduced item set facilitates development of short screening tools suitable for use in clinical applications or research studies. This study represents the first step in the establishment of an item bank for delirium screening with potential questions for clinical researchers to select from and tailor according to their research objectives.
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Bmc Med Res Methodol · Jan 2013
Comparative StudyIs a large scale community programme as effective as a community rehabilitation programme delivered in the setting of a clinical trial?
The rationale for commissioning community pulmonary rehabilitation programmes is based on evidence from randomised clinical trials. However, there are a number of reasons why similar programmes might be less effective outside the environment of a clinical trial. These include a less highly selected patient group and less control over the fidelity of intervention delivery. The main objective of this study was therefore to test the hypothesis that the real-world programme would have similar outcomes to an intervention delivered in the context of a clinical trial. ⋯ The before-after changes in outcomes seen in a "real world" community rehabilitation programme are similar in magnitude to those seen in the intervention arm of a clinical trial. However suboptimal uptake and high dropout rates from rehabilitation amongst eligible participants occurs in both clinical trials and community based programmes and must be addressed if the benefits of rehabilitation for people with chronic lung disease are to be maximised.
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Bmc Med Res Methodol · Jan 2013
An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database.
There is little published guidance as to the sample size required for a pilot or feasibility trial despite the fact that a sample size justification is a key element in the design of a trial. A sample size justification should give the minimum number of participants needed in order to meet the objectives of the trial. This paper seeks to describe the target sample sizes set for pilot and feasibility randomised controlled trials, currently running within the United Kingdom. ⋯ All studies should have a sample size justification. Not all studies however need to have a sample size calculation. For pilot and feasibility trials, while a sample size justification is important, a formal sample size calculation may not be appropriate. The results in this paper describe the observed sample sizes in feasibility and pilot randomised controlled trials on the UKCRN Database.
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Bmc Med Res Methodol · Jan 2013
A comparison of Cohen's Kappa and Gwet's AC1 when calculating inter-rater reliability coefficients: a study conducted with personality disorder samples.
Rater agreement is important in clinical research, and Cohen's Kappa is a widely used method for assessing inter-rater reliability; however, there are well documented statistical problems associated with the measure. In order to assess its utility, we evaluated it against Gwet's AC1 and compared the results. ⋯ Based on the different formulae used to calculate the level of chance-corrected agreement, Gwet's AC1 was shown to provide a more stable inter-rater reliability coefficient than Cohen's Kappa. It was also found to be less affected by prevalence and marginal probability than that of Cohen's Kappa, and therefore should be considered for use with inter-rater reliability analysis.